Combination OTC painkillers gaining ground

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Following the approved switch of Voltaren Arthritis Pain by the FDA in mid-February, there was more positive news for GSK’s US analgesics portfolio over the weekend with the FDA approval of Advil Dual Action. This is the first FDA-approved OTC combination of ibuprofen and paracetamol (acetaminophen) in the USA, and GSK is expected to launch the product later this year.

Franck Riot, Head of R&D at GSK Consumer Healthcare, said: “For decades, many consumers have been using ibuprofen and acetaminophen (paracetamol) to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain. Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option – a single, fixed-dose combination pain reliever.” According to the reported clinical research, this fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone.

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Dolostop Plus, another recent combination launch

Another combination OTC painkiller we tracked recently, formulated with both ibuprofen and paracetamol, is Kern’s September 2019 launch of Dolostop Plus in Spain. Indicated to provide symptomatic relief from mild to moderate pain in adults, these film-coated tablets are formulated with paracetamol 500mg and ibuprofen 150mg, with a stated dose of 1-2 tablets every 6 hours, and claimed to be the first and only OTC paracetamol and ibuprofen combination available in Spain.

In several markets around the world, such as the UK, Russia, Japan and Indonesia, combination paracetamol + ibuprofen OTC remedies are already well-established, but these recent developments in the USA and Spain point to growing acceptance among global regulators about the safety of fixed-dose OTC analgesic combinations.

Where will NPD take the CHC market in the future? Find out in our upcoming report, Innovation in CHC: NPD & Innovation in CHC under the Spotlight! This report, drawing on Nicholas Hall’s CHC New Products Tracker, assesses the global picture of CHC innovation in 2019, featuring ingredient trends, delivery format trends, analysing innovation trends by region and by marketer, plus much more! To pre-order your copy and save with the pre-publication discount, or for more information, please contact melissa.lee@NicholasHall.com.

GSK and Alcon get FDA approval for US switches

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Following on from our recent blog highlighting the need for a new wave of Rx-to-OTC switches to kickstart growth in the global consumer healthcare industry, this week we cover the welcome news that the FDA has approved three drugs for non-prescription use. As well as GSK’s topical analgesic gel Voltaren Arthritis Pain (diclofenac sodium 1%), two Alcon eye care allergy products (available as solution / drops) have also switched to OTC status – Pataday Twice Daily Relief (olopatadine 0.1%) and Pataday Once Daily Relief (olopatadine 0.2%).

Karen Mahoney, Acting Deputy Director of the Office of Nonprescription Drugs at the FDA’s Center for Drug Evaluation & Research, said: “Approval of a wider range of non-prescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

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Olopatadine is available OTC in a handful of other countries worldwide, but this is the first time it’s been switched in a major market. One of the countries where the ingredient can be purchased without a prescription is Singapore, which approved the Rx-to-OTC switch of olopatadine 0.1% and 0.2% in December 2016. More recently, Poland’s Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) approved the Rx-to-OTC switch of Polfa Warszawa’s Starelltec Alergia eye drops (olopatadine 1mg / ml; 5ml bottle) in July 2019 and Adamed’s Oftahist eye drops (olopatadine 1mg / ml; 5ml bottle) in November 2019.

Voltaren currently ranks fifth among the world’s leading consumer healthcare brands, according to CHC DASHBOARD, and this switch could see it move up the rankings and even move ahead of its new GSK stablemate Advil into the No.3 position globally within the next few years. While the US switch of Voltaren has long been mooted, the news is all the more welcome at a time when the world’s No.1 CHC market is in desperate need of an injection of growth, and US arthritis sufferers are also in need of a wider pool of OTC non-opioid treatment options.

For the full story, be sure to read tomorrow’s edition of CHC.NewDirections, a weekly e-newsletter sent out every Tuesday. CHC.NewDirections focuses on innovation, science and regulation, and coverage spans Rx-to-OTC switch, CBD, relevant medical research, probiotics, medical devices, digital health / AI, e-cigarettes and much more! For more information, or to arrange a free trial, please contact Melissa.Lee@NicholasHall.com

GSK and Sanofi seek to stand alone

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Structural reorganisation is on the agenda of two of the world’s leading CHC marketers in 2020. GSK’s consumer health tie-up with Pfizer in August 2019 was last year’s major M&A development and now the company’s next ambition is to list the new CHC business on the London Stock Exchange. As for Sanofi, the company unveiled a new strategy just before Christmas, including making Sanofi Consumer Healthcare a standalone business. In the meantime, both companies continue to trim their CHC portfolios.

In December 2019, Pfizer agreed to divest its topical pain management business, ThermaCare, to Italian-based Angelini for an undisclosed sum, reports apotheke.adhoc.de. In July 2019, the European Commission approved the consumer healthcare merger of GSK and Pfizer, conditional upon the global divestment of ThermaCare. The agreement follows Angelini’s acquisition of BoxaGrippal systemic cold & flu remedy and the Heumann herbal medicinal tea range from Sanofi in August 2019.

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Meanwhile, it was announced this month that BI is to sell Buscopan antispasmodic and Buscofem menstrual pain analgesic to Hypera Pharma in Brazil for Rs1.3bn (US$329mn). The deal, which is subject to approval by Administrative Council for Economic Defence (CADE), is in line with Hypera’s strategy of strengthening its portfolio with “established brands with high growth potential”. Under the terms of its 2017 business swap with BI, Sanofi has acquisition preference for the brands and could still pose a counteroffer. However, industry sources suggest that the company is unlikely to exercise this right.

In December 2019, Sanofi unveiled a new strategy to drive innovation and growth, focusing on three core global business units: Specialty Care, Vaccines and General Medicines. Consumer Healthcare will be a standalone business unit with integrated R&D and manufacturing functions. CEO Paul Hudson explained: “Our objective for the CH business is to unlock value and entrepreneurial energy by growing faster than the market over the mid-term. We believe the new standalone structure, coupled with plans to accelerate the OTC switches for Cialis and Tamiflu, will position the business well to accomplish this ambition.” Hudson added that the Rx erectile dysfunction treatment and flu remedy are expected to switch by 2026, adding around US$1bn to Sanofi’s top line.

Are you looking to make a strategic or bolt-on acquisition? If so, our Consultancy team would be happy to have a confidential discussion with you. Our specialist team can negotiate the successful acquisition of companies and brands, asset swaps, fostering and financing. We work with a number of strategic and financial partners to evaluate potential opportunities – for buyers and sellers – in the M&A, licensing and fundraising space. To find out more, please contact ekaterina.panteleeva@NicholasHall.com.

CHC Adjacencies Fuelling Digital Marketing Innovation

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A new report from Nicholas Hall examines effective digital marketing strategies for consumer health players and the fast-growing online channel for OTCs. In this week’s blog, we examine which consumer healthcare categories, brands and companies most fully embraced social media marketing in 2019, and summarise the report’s findings.

Given the tight regulations surrounding the promotion of registered OTC medicines on social media, it’s no surprise that the subcategories where we’ve recorded the most digital marketing activity in 2019 – using our OTC New Products Tracker tool – were adjacent categories in Lifestyle OTCs, VMS and dermatologicals. Cannabis / CBD recorded the highest number of innovations backed by social media promotion in 2019, followed by lip care and probiotics.

Of the Top 20 brands that recorded the highest number of innovations in 2019 backed by social media promotion, lip care products Eos (Eos) and ChapStick (formerly Pfizer, now GSK) were at the top of the tree. For example, Eos Vampire Kiss was supported by an Instagram campaign in the run-up to Halloween. CBD companies such as Hilo, CBDfx and Ignite – the latter backed by professional poker player and social media celebrity Dan Bilzerian – have also used digital marketing in 2019 to support their new products. Among VMS brands, Irwin Naturals, Zarbee’s Naturals (J&J) and Olly (Unilever) were all well-supported on social media, especially Facebook.

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Below are some of the findings from the new Nicholas Hall report:

  • It is vital that approaches to digital marketing are differentiated across digital and social media channels
  • Most consumers trust social media for healthcare advice, making an engaging social media strategy critical
  • Rapid adoption of digital technologies and evolving shopping behaviours are transforming e-Commerce into a key channel in consumer healthcare
  • Consumers will generally shop where it is most convenient, so understanding where they are shopping online is vital
  • Mobile is consumers’ constant companion so all content should be accessible on mobile devices
  • Since the virtual shelf is infinite, standing out from competitors online requires orchestrated brand communication

Comment from Ian Crook, Managing Editor, Nicholas Hall’s Reports: When considering how to target consumers via digital channels, marketers must note that different demographic groups use different social media platforms, and in diverse ways. Content consumption is diversifying just as audiences are broadening; the modern consumer leads a very busy life and can be easily distracted, posing challenges to effective engagement. Fostering consumer connections is vital, and whichever means of communication is used – live streaming, chatbots, social media messaging, etc – interacting with consumers is essential. Marketers cannot win everywhere or invest in all platforms, so choosing the appropriate medium is an important step in planning an effective digital campaign.

The new report features many more findings, backed by relevant case studies, including a look at consumer influencers, the benefits of a direct-to-consumer strategy, the digital strategies of the OTC Top 10, as well as the differing regulatory situation for online sale of medicines across markets, plus much more. To purchase your copy of Digital Marketing & e-Commerce, or for more details, please contact melissa.lee@NicholasHall.com.

Highlights from OTC DASHBOARD’s Q2 update

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The latest quarterly report on the global OTC market is now available on the OTC DASHBOARD website, including data & trends on the market’s performance at a global, regional and Top 20 country level in the year to end-June 2019. Here we highlight some of the key topline trends from this Q2 update, selecting one major global development from each of our company, category and brand watch sections.

Company Watch

M&A activity completed in 2019 has seen a reshuffle in the rankings of the top global OTC marketers; most notably, GSK is now by far the No.1 consumer healthcare marketer globally, following the closure of its OTC merger with Pfizer in August 2019, giving it a 6.8% share. This consolidation has led to the emergence of new competitors, most notably By-Health, which has broken into the global Top 20 and now claims 15th spot.

While decelerating growth in Emerging Markets, especially China, has been a key macroeconomic trend affecting the wider economy and the consumer healthcare industry, one company that has bucked the trend with accelerating growth (+31%) is By-Health. China accounts for over 90% of By-Health’s OTC portfolio turnover, with Australia accounting for the remainder. In China, the company fields brands including dynamic longline range By-Health and glucosamine supplement Keylid, backed by an intensive A+P strategy.

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Category Watch

Analysing the performance of the major OTC categories at a global level, gastrointestinals enjoyed the fastest growth in the MAT Q2 2019 period, with sales up 4.9%. Antinauseants (+15.9%) performed especially well, recorded a strong performance in Asia-Pacific, the largest regional market for GIs, owing to increasing levels of travel and changing diets.

Antidiarrhoeals, antispasmodics & IBS remedies and liver & bile remedies were the other best-performing categories, powered by new product innovation, as explored more fully in our Q2 update. One cloud on the horizon for GIs are the global concerns and recalls affecting antacids containing ranitidine, after some medicines were recently found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels — see our previous blog for more details.

Brand Watch

Two OTC brands have global sales of over US$1bn — Vicks (P&G) and Tylenol (J&J) — and both continue to outperform the global OTC market. No.1 Vicks produced above-average growth of 5.7%, despite difficult conditions in the global cough, cold & allergy market.

A strong return to growth in North America for Vicks was at the heart of this upturn, allied with continued strong growth in Latin America, helping to offset the moderate continued decline in Europe. A major factor driving faster growth in North America for Vicks is the sedative & sleep aid range Vicks ZzzQuil, which was boosted by the US launch of a new Pure Zzzs line in 2018. This range has been extended further with Pure Zzzs Kidz in Q3 2018 and several beauty and de-stress gummy supplements in 2019.

Whether you are in the office or on the go, you can access reliable CHC data and trends from OTC DASHBOARD, accessible on tablet, smartphone and desktop, and covering 63 markets across the world. Contact Hannah.Burke@NicholasHall.com to find out how you can benefit from OTC DASHBOARD by setting up a free trial today!

What future for AI in healthcare?

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One of the chapters in Nicholas Hall’s recently published New Paradigms report, entitled The Digital Revolution, provides some compelling examples of consumer healthcare companies and OTC brands that are thriving in the digital era. While key marketers like GSK were slow to invest in digital, the tide is now turning – in its 2018 annual report, GSK said it had “significantly” increased its advertising spend in online media because it is delivering a “far higher return” than traditional TV – despite continuing reservations from some companies like P&G about the way digital budgets are deployed.

One emerging technology that has an uncertain future in healthcare is artificial intelligence. Back in March, a report published by MMC Ventures (in partnership with Barclays) predicted that AI can “unlock a paradigm shift in healthcare”, particularly in diagnosis, drug discovery and monitoring. According to MMC’s research, health & wellbeing is a “focal point” for AI entrepreneurship – 21% of start-ups serve the sector, more than any other sector – and, over the next decade, “developers will have a greater impact on the future of healthcare than doctors”.

An example of innovation here is L’Oreal’s augmented reality and artificial intelligence entity, ModiFace, which has led to the launch of a consumer digital skin ageing diagnostic tool. Targeting women, its first application is Vichy SkinConsultAI – based on ModiFace’s AI-powered algorithm – launched in Canada in January 2019 and rolling out across the brand’s websites globally over the course of this year.

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However, security concerns continue to be the main stumbling block for AI. According to research published in Digital Health last month, public concern about accuracy, cybersecurity and the inability of AI-led chatbots to sympathise may be standing in the way of artificial intelligence’s successful introduction into healthcare.

A University of Westminster-led team surveyed 216 participants on a range of demographic and attitudinal variables including questions about acceptability and perceived effectiveness of AI in healthcare. The results identified three broad themes: “understanding of chatbots”, “AI hesitancy” and “motivations for health chatbots”. The team suggests that designers of AI-led chatbots need to employ user-centred and theory-based approaches to address patient concerns and to optimise user experience in order to achieve the best uptake and utilisation.

Embracing Tech and Digital Health are two of the key themes at our OTC.NewDirections Executive Conference, taking place in London on 14 November 2019! Nicholas Hall will be joined by experts from companies including Bayer, Mundipharma and J&J to review these issues, as well as others impacting our industry, including the status of Medical Cannabis in Europe, Growing Brands through Innovation and the ultimate theme of ensuring that you are Keeping Consumers in the Spotlight. To find out more, or to reserve your place, please contact jennifer.odonnell@NicholasHall.com without delay!

Pfizer-GSK j-v approved, Pfizer-Mylan to close mid-2020

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At the end of last week, it was announced that GSK and Pfizer have closed their j-v, combining the groups’ respective consumer healthcare businesses to create the world’s largest CHC company. According to the latest MAT Q1 2019 data (see table below), this new entity – which will operate globally as GSK Consumer Healthcare – will become the standout No.1, increasing its global share from around 4% to roughly 7%, though of course divestitures will be necessary. Those already identified include ThermaCare (by the EU authorities) and Pfizer’s antacid tablet business (by the Brazil authorities), while some OTC brands (like Viagra Connect) will stay with Pfizer.

As previously announced, under the deal Pfizer owns a 32% equity stake in the j-v and GSK owns 68%. The combined company, which will be led by CEO Brian McNamara, will take leadership positions in pain relief, respiratory, VMS and therapeutic oral health. The new business will also hold the No.1 CHC spot in the USA and the No.2 position in China. As part of the agreement, Pfizer has appointed three of the nine members of the j-v’s board. GSK intends to separate the j-v as an independent company via a demerger of its equity interest to its shareholders and will list it on the UK equity market.

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In the same week, Pfizer announced plans to enter into a definitive agreement to combine Upjohn, its off-patented branded and generics business, with Mylan. The new company, which will be renamed and rebranded when the transaction closes (expected mid-2020), will expand the capabilities of both Mylan and Pfizer across 165+ markets. Mylan brings a diverse portfolio across many geographies and key therapeutic areas, while Upjohn brings iconic brands such as Lipitor, Celebrex and Viagra and leadership positions in China and other emerging markets.

The combination will drive a diverse portfolio of Rx medicines, complex generics, OTCs and biosimilars. It will be based in the USA and led by Mylan’s current Chairman Robert Coury, who will serve as Executive Chairman. Pfizer shareholders will own 57% of the new company and Mylan shareholders will own 43%. The new company is expected to have pro forma 2020 revenues of US$19bn-20bn.  

Commenting on the deal, Nicholas Hall said: “The new company will be a top CHC player, owing to Mylan’s 17th ranking, plus the Viagra Connect business and sundry other Pfizer CHC brands that didn’t go into the GSK j-v. That could well move NewCo into the Top 10. The questions in my mind are: will NewCo keep these assets or sell them on; and (more importantly) will it license out the rights to what is one of the best switch portfolios in the industry or manage the switches themselves.”

The evolving OTC market will be under the spotlight in our forthcoming report, Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, written by Nicholas himself! Other chapters will include Healthcare Trends, Regulation, Digital engagement amongst many others. Nicholas will also unveil the 15 “Infinity Zones” he has identified as being crucial to the future growth of the industry. You can upgrade your purchase to include a customised in-house presentation or webinar with Nicholas for an additional GB£10,000. To find out more or to pre-order your copy, please contact melissa.lee@NicholasHall.com.